Catheter design was key for the Boston Scientific Farapulse pulsed field ablation system

Boston Scientific Chief Medical Officer Dr. Ken Stein explains how catheter design drives the Farapulse pulsed field ablation system.

This image depicts the Boston Scientific Farapulse PFA system’s Farawave ablation catheter in its flower shape. [Image courtesy of Boston Scientific]

Following FDA approval on Jan. 31, Farapulse from Boston Scientific is now the second pulsed field ablation (PFA) system approved to treat atrial fibrillation (AFib) in the U.S.

Medtronic’s PulseSelect PFA System picked up the first FDA approval in December for the treatment of paroxysmal and persistent AFib.

Boston Scientific’s Farapulse, on the other hand, is indicated for the isolation of pulmonary veins to treat drug-refractory, recurrent, symptomatic, paroxysmal AFib.

Farapulse delivers pulsed field energy using the Farawave ablation catheter, Farastar ablation generator and Faradrive steerable s…

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What’s so special about pulsed field ablation? Medtronic EVP Sean Salmon explains

The Medtronic PulseSelect Pulsed Field Ablation (PFA) System is designed to treat paroxysmal and persistent atrial fibrillation (AFIb). [Image courtesy of Medtronic]

Medtronic’s PulseSelect Pulsed Field Ablation (PFA) System — which won the first FDA approval for PFA to treat atrial fibrillation (AFib) — is just the start of a wave of new PFA devices expected to hit the market.

Medtronic is lining up another PFA cardiac ablation system for approval, while competitor Boston Scientific anticipates approval of its Farapulse PFA system sometime in 2024. Meanwhile, Johnson & Johnson’s Biosense Webster is testing its ThermoCool SmartTouch SF system for both PFA and radiofrequency ablation.

Medtronic EVP and Cardiovascular President Sean Salmon recently discussed PFA technology in an interview with Medical Design & Outsourcing before the world’s largest medical device manufacturer anno…

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Medtronic execs: renal denervation for AFib could be on the horizon

The Medtronic Symplicty Spyral renal denervation (RDN) catheter delivers radiofrequency energy from four electrodes to ablate nerves in the renal arteries and treat high blood pressure. The nitinol-based device expands in a spiral pattern inside the blood vessel. [Image courtesy of Medtronic]

Medtronic renal denervation leaders Jason Weidman and Sean Salmon discuss RDN’s potential to help patients with atrial fibrillation (AFib).

As if treating an epidemic-level condition like hypertension wasn’t enough, renal denervation (RDN) also shows potential for atrial fibrillation (AFib) and other conditions related to high blood pressure.

In interviews with Medical Design & Outsourcing, Medtronic EVP Sean Salmon and SVP Jason Wediman discussed whether their Spyral Symplicity radiofrequency (RF) catheter ablation technology could help AFib patients when paired with cryoablation.

Weidman — pres…

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How Medtronic evaluates its exposure to GLP-1 drugs

Medtronic Chief Scientific, Medical and Regulatory Officer Dr. Laura Mauri drills into GLP-1 drug trial results to estimate their impact across the portfolio.

“We’ve done all the analysis” on GLP-1 drugs across Medtronic’s portfolio, said CEO and Chair Geoff Martha. [Photo courtesy of Medtronic]

The impact of glucagon-like peptide-1 (GLP-1) drugs like Ozempic and Wegovy on medtech manufacturing is one of the biggest uncertainties heading into 2024.

Industry leaders like Medtronic, Stryker and Intuitive have faced questions from investors about whether these weight loss drugs will reduce demand for certain medical devices and procedures.

Despite a portfolio spanning some of the fields that would seem likely to be affected — such as cardiovascular, diabetes, surgical and neurovascular — Medtronic Chair and CEO Geoff Martha recently said the drugs won’t impact his company’…

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How Biosense Webster aims to expand access to AFib care

Biosense Webster U.S. President Nikki Sidi [Image courtesy of Biosense Webster]

Electrophysiology is “an incredibly vibrant space,” said Nikki Sidi, but access remains a challenge.

Nikki Sidi, the U.S. president of Johnson & Johnson’s Biosense Webster, can look at her own company as one of those paving the way in electrophysiology (EP). Its recent milestones include multiple atrial fibrillation (AFib) mapping catheters, including ablation and mapping devices. 

Sidi has worked across a number of businesses at J&J, including leading U.S. marketing for Biosense Webster. She took on the post of U.S. president at Biosense Webster in December 2022 after a stint with J&J Vision. 

Her return to Biosense Webster — and her return to AFib treatments — has been nothing short of “amazing,“ she said in an interview. Biosense Webster competes in a market that also includes …

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Boston Scientific’s Farapulse PFA system is poised for FDA approval, analysts say

The Farapulse system’s Farawave single-shot ablation catheter expands inside the patient to deliver energy for treating AFib. [Image courtesy of Boston Scientific]

Boston Scientific’s Farapulse pulsed-field ablation (PFA) system likely hit its primary endpoints, according to Needham analysts who say that means the technology is poised for FDA approval.

Boston Scientific has already said it expects FDA approval of Farapulse next year, but has not yet shared results from its ADVENT pivotal trial.

That data is set for release on Aug. 27 at the 2023 European Society of Cardiology (ESC) Congress. The device developer started that trial in March 2021 and stopped enrolling patients in June 2022.

Based on the trial’s adaptive design with a varying number of possible patients — 350, 450, 550, 650 or 750 — and the timing of enrollment, the Needham analysts say they suspect Boston Scientifi…

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Boston Scientific ramps up Farapulse manufacturing with new site

The Farapulse pulsed-field ablation system’s Farawave catheter (pictured) uses an energy field generated by the Farastar to treat atrial fibrillation. [Image courtesy of Boston Scientific]

Boston Scientific plans to increase production of its Farapulse pulsed-field ablation (PFA) system with a second pulse generator manufacturing site.

“Demand for the platform far exceeds our ability to supply thus far,” Boston Scientific Chair and CEO Mike Mahoney said on yesterday’s earnings call.

He soon after shared that the device developer “just recently received GMED approval for a manufacturing approval to actually manufacture this in Minnesota.”

Paris-based GMED is a notified body designated by France for conformity assessment under the EU Medical Devices Regulation (MDR).

Farapulse Inc.  secured CE mark approval for the system before being acquired by Boston Sci…

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5 growth areas where Medtronic’s CEO wants to invest more

Medtronic CEO and Chair Geoff Martha [Photo courtesy of Medtronic]

With Medtronic selling off and spinning off businesses, CEO and Chair Geoff Martha recently shared his strategy on divestitures and the high-growth areas where he wants to invest more.

Martha was speaking at this month’s Goldman Sachs Annual Global Healthcare Conference, where he also offered his perspective on labor conditions, supply chain issues, international markets, plans to increase R&D spending and the latest on the Hugo surgical robotics system.

How Medtronic — the world’s largest medical device company — and its leader think about which businesses to sell and which to build can help competing device developers, partners and suppliers better understand medtech’s changing landscape.

Medtronic’s divestiture strategy

Medtronic announced plans in May 2022 to spin off its kidney care/dialysis busines…

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FDA clears Samsung Galaxy smart watch for AFib detection

[Image courtesy of Samsung]Samsung Electronics announced that the irregular heart rhythm notification feature of its health monitor app received FDA clearance.

Combined with the app’s existing on-demand ECG function, the feature proactively monitors heart rhythms suggestive of AFib. It all works straight from the user’s wrist through the Samsung Galaxy Watch.

“We’re excited to announce that irregular heart rhythm notification, designed to help millions of people around the world who may not be aware of a potential heart risk, has been cleared by the FDA,” said Hon Pak, VP and head of the digital health team, MX business at Samsung Electronics. “This is yet another example of how Samsung prioritizes proactive safety solutions and enables users to receive a more holistic understanding of their cardiovascular and overall health.”

Galaxy Watch utilizes the Samsung BioActive sensor. It includes on-demand ECG recording and heart rhythm alert functions…

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Pulse Biosciences enters $65M private placement for pulsed-field ablation tech

Pulse Biosciences (Nasdaq:PLSE) announced today that it entered into a stock purchase agreement to raise approximately $65 million.

Hayward, California-based Pulse Biosciences entered into the agreement with Robert Duggan, the company’s executive chair. Duggan agreed to purchase 10,022,937 shares of the company’s common stock at $6.51 per share. That marks a greater than 1% premium over the last reported sale price of Pulse common stock on April 28, 2023.

Upon the closing of the private placement, all indebtedness owed to Duggan will be canceled as consideration for the shares. That includes the principal balance of $65 million and accrued and unpaid interest of approximately $0.25 million.

Pulse Biosciences develops its novel and proprietary nanosecond pulsed field ablation (nsPFA) technology. It also develops the proprietary CellFX System for the treatment of AFib.

“Upon closing, this transaction eliminates our debt and this ca…

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Biosense Webster marks first cases with dual energy ablation tech

The Thermocool SmartTouch SF ablation catheter [Image courtesy of J&J’s Biosense Webster]Biosense Webster today announced the first cases with its investigational Thermocool SmartTouch SF dual energy catheter for treating AFib.

The system enables doctors performing an ablation to toggle between two types of energy: pulsed-field and radiofrequency. It appears to be the Johnson & Johnson MedTech subsidiary’s answer to the dual energy ablation tech coming out of Affera, which competitor Medtronic acquired for $1 billion last year.

Dr. Tom De Potter performed the first procedure with Thermocool SmartTouch at OLV Hospital in Aalst, Belgium. Biosense Webster said Dr. Mattias Duytschaever of AZ Sint-Jan Brugge Oostende AV performed several additional cases. The Brugge, Belgium, hospital is also taking part in the clinical trial.

“While radiofrequency ablation has decades of safety and efficacy data to support it, pulse field ablation is a novel…

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Medtronic: Linq monitor boosts AFib detection 10-fold among stroke patients

The Reveal Linq implantable cardiac monitor (ICM). [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today announced clinical data demonstrating significant improvements in AFib detection using the Reveal Linq.

The study compared the Reveal Linq insertable cardiac monitor (ICM) to patients randomized to standard of care. Those patients did not receive continuous long-term monitoring. Medtronic presented the three-year data at the American Stroke Association’s International Stroke Conference (ISC) 2023.

According to a news release, it builds on the 12-month Stroke AF study data published in JAMA in June 2021. The data includes about a 10-fold increase in AFib detection with the Reveal Linq technology.

Reveal Linq detected AFib in 12.5% of patients compared to 1.8% of patients randomized to standard of care. The standard of care techniques included 12-lead ECGs, Holter monitoring, telemetry or event recorders. At three years, the rate of AFib detection …

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